Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT03382769
Status:
TERMINATED
Last Update Posted:
2022-12-22
First Post:
2017-12-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hearing Loss in Older Adults Study
Sponsor:
Cochlear
Organization:
Study Overview
Official Title:
Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early terminated due to COVID-19 public health emergency, with a patient population in vulnerable populations (older adults) seeking cochlear implantation as elective Standard of Care.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: